Halaven° contains eribulin in the form of a salt ‘eribulin mesilate’, which releases the active substance. In line with European Union (EU) guidelines, the strength is expressed in the product information in terms of the active substance, eribulin. However, the strength of Halaven is often expressed in terms of the salt in the scientific literature as well as in the prescribing information used in some countries, including the United States of America (USA). The expression of strength in the EU product information could be misunderstood by healthcare professionals to be referring to ‘eribulin mesilate’ rather than to eribulin, which could potentially lead to the wrong dose being given to patients.
- ISMP-Spain Nota de advertencia Riesgo de sobredosificación con eribulina (Halavén°), 26 December 2011 Download PDF
- IMSN Letter to Guido RASI, Executive Director, EMA, 27 January 2012 Download PDF
- EMA Questions and answers on the expression of the strength for Halaven (eribulin), 16 February 2012 Download PDF
- EMA Letter to Mr Michael R Cohen, IMSN - Labelling of Eribulin, 20 February 2012 Download PDF